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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHARISMA; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION CHARISMA; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number D332
Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574); Interrogation Problem (4017)
Patient Problems Shock (2072); Electric Shock (2554)
Event Date 03/02/2023
Event Type  Injury  
Event Description
It was reported that this patient went into the physician office after receiving 2 shocks.The physician reported being unable to interrogate the implantable cardioverter defibrillator (icd) device.The patient was admitted to the hospital.A revision procedure was completed.Interrogation of device post explant revealed device was in safety mode with a premature battery depletion.A boston scientific representative stated the physician was not able to determine if the shocks the patient received prior to explant were appropriate or not.A new device was implanted.Besides surgical intervention no adverse patient effects were reported.The device is expected to be returned for analysis.
 
Manufacturer Narrative
At this time the device has not been returned.Therefore a technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.If the device is returned, product analysis will be completed, and an updated supplemental report will be submitted.
 
Event Description
It was reported that this patient went into the physician office after receiving 2 shocks.The physician reported being unable to interrogate the implantable cardioverter defibrillator (icd) device.The patient was admitted to the hospital.A revision procedure was completed.Interrogation of device post explant revealed device was in safety mode with a premature battery depletion.A boston scientific representative stated the physician was not able to determine if the shocks the patient received prior to explant were appropriate or not.A new device was implanted.Besides surgical intervention no adverse patient effects were reported.
 
Manufacturer Narrative
A thorough evaluation of the device was performed upon receipt at our post market quality assurance laboratory.Visual inspection of the device noted scratches and tool marks on the case and header.With a small dent on the case in the back.The case was swollen in the area of the hv capacitors.Review of device memory indicated that a charge timeout alert (> 45 seconds) had been recorded.The device case was opened, and visual inspection noted that one of the two high voltage (hv) capacitors was slightly swollen.The hv capacitor was analyzed, and it was concluded that the hv capacitor experienced internal arcing caused by a low resistance pathway between anode and cathode plates within the capacitor.This capacitor issue impacted the ability of the device to provide shock therapy because the hv capacitors could not be fully charged, but brady pacing, telemetry, and other device functionality remained available.
 
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Brand Name
CHARISMA
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key16539668
MDR Text Key311254567
Report Number2124215-2023-12001
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeEZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/06/2023
Device Model NumberD332
Device Catalogue NumberD332
Device Lot Number280086
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/09/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/18/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age55 YR
Patient SexMale
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